The NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (amended in 2001 and 2018) explains that all NIH-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of all sexes/genders, races, and ethnicities, and (particularly in NIH-defined Phase III clinical trials) to examine differential effects on such groups.
The NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects explains that principal investigators (PIs) must make efforts to include all age groups, especially children (<18 years) and older adults (≥65 years), so that study populations are representative of the target patient population.
The goal of this effort is to ensure that the clinical research supported by NHLBI is both diverse and inclusive, where the principles of beneficence and justice lead to generalizable, evidence-based medicine.
Prior to making awards, NHLBI will examine each grant application to ensure that it complies with the NIH policies and guidelines. The expectation for NHLBI-funded studies is that the proposed study population is appropriate for the scientific aims of the study. The targeted study population will reflect the age/gender/race/ethnic distribution of the population affected by the disease/condition under study, or if such information is not available, the study population should reflect the composition of the overall U.S. population (51% women, 30% minorities). Exceptions are permitted only when a valid scientific justification for limited inclusion exists; the law states explicitly that cost is not a permissible justification.
Katie Kavounis, MPH
National Heart, Lung, and Blood Institute
6705 Rockledge Drive, Room 308-D
Bethesda, MD 20892
Last Updated: July 2020